Medicare’s New Device-Coverage Pathway — Breakthrough or Breakdown?

CMS recently finalized a rule that could substantially alter Medicare-coverage decisions for certain new medical devices. The rule is intended to expedite coverage, but it would undermine Medicare’s authority to consider the clinical evidence supporting device adoption.

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Bibliographische Detailangaben
Veröffentlicht in:	The New England journal of medicine 2021-03, Vol.384 (12), p.e43-e43
Hauptverfasser:	Rathi, Vinay K, Johnston, James L, Ross, Joseph S, Dhruva, Sanket S
Format:	Artikel
Sprache:	eng
Schlagworte:	Centers for Medicare and Medicaid Services, U.S Clinical medicine Collaboration Contractors Device Approval - legislation & jurisprudence Device Approval - standards Equipment and Supplies - economics FDA approval Government Regulation Insurance Coverage - economics Insurance Coverage - legislation & jurisprudence Medical device industry Medical equipment Medicare United States United States Food and Drug Administration
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Beschreibung
Zusammenfassung:	CMS recently finalized a rule that could substantially alter Medicare-coverage decisions for certain new medical devices. The rule is intended to expedite coverage, but it would undermine Medicare’s authority to consider the clinical evidence supporting device adoption.
ISSN:	0028-4793 1533-4406
DOI:	10.1056/NEJMp2101874